Innovation brings risk. Pharma is risk averse. Therefore, we have less innovation than in other industries. Most likely you’ve heard it all before. But is it valid? We talk to executives from Biogen, Merck, and Sanofi Biologics to find out.
The readers of this occasional column on the basics of Six Sigma applied in the pharma space are likely aware that we’re at our final step in our Six Sigma DMAIC roadmap, that of Control.
My previous article on the regulatory and quality aspects of M&A technical due diligence looked at how to ensure you acquire products that can be outsourced properly to a third-party manufacturer. This second part will cover considerations for the manufacturing process and equipment as well as some aspects of logistics and operations.
In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. Part 2 provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
With things “heating up” in terms of more diverse temperature demands, the industry is moving away from the term cold chain, and we’ll start to see more references to the more inclusive temperature-controlled transport.
Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.
Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.
Crucial to the successful operation of any research laboratory is the ability to efficiently generate purified proteins for further investigation and analysis. By Per Lidén (GE Healthcare Life Sciences), Svend Kjær (Cancer Research UK) and Mark Cooper (Abcam)
Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.
Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.
Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.
Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.
With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.
Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.
The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors. The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process. The result: A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System.
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. Forecasting and demand simulations are useful for anticipating when and where stock is likely to be needed to formulate a kit production and distribution strategy.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.
Pharmaceutical companies face a number of challenges when sourcing comparator compounds for clinical trials, including addressing product lead times, availability, expiry limitations, safety or cost. Learn how clinical trial sponsors can determine the best strategy to meet these challenges.